Cleared Traditional

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

K223026 · Northeast Scientific, Inc. · Cardiovascular
Feb 2023
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K223026 is an FDA 510(k) clearance for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on February 3, 2023, 127 days after receiving the submission on September 29, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K223026 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date February 03, 2023
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code OWQ — Reprocessed Intravascular Ultrasound Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.

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